BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER

    MDR report key: 3191479 · Received June 26, 2013

    Report

    Report Number
    2183870-2013-00156
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 21, 2013
    Manufacturer
    EV3 INC.
    Product Code
    LIT
    PMA / PMN Number
    K130911
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE BALLOON WAS MISSING AS WAS MOST OF THE INNER SHAFT . THE RX SECTION AND THE 1CM REMAINING SECTION OF THE GUIDEWIRE LUMEN EXHIBITED A LONGITUDINAL TEAR TO THE PROXIMAL BALLOON BOND NECK.

    Description of Event or Problem · 1

    RIGHT PEDAL ACCESS AND RIGHT CHRONIC TOTAL OCCLUSION (CTO). THE RAPIDCROSS COULD NOT CROSS PAST PEDAL SHEATH. WHEN THE PHYSICIAN REMOVED THE RAPIDCROSS FROM THE BODY, THE COATING LOOKED LIKE IT CAME OFF. A NEW RAPIDCROSS WAS PULLED.INVESTIGATION OF THE RETURNED DEVICE FOUND THE BALLOON WAS MISSING AS WAS MOST OF THE INNER SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291308 RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT EV3 INC. A14BX030060170 9714182

    Patients

    Seq Age Sex Outcome Treatment
    1 Other JOURNEY .014 WIRE